Compliance & Validation Analyst

Emergo Group   •  

Princeton, NJ

Industry: Finance & Insurance

  •  

5 - 7 years

Posted 38 days ago

This job is no longer available.

The Compliance & Validation Analyst is responsible for the validation of software quality assurance during the software development cycle. This position oversees process control, auditing, training, corrective actions and preventative actions, and conducting management review meetings pertaining to UL's primary training software development products (e.g., ComplianceWire, Learnshare and UL Create.


Responsibilities

  • Acts as an agent of change to lead supplementing existing quality management systems controls and process improvements.
  • Ensures due diligence and accuracy for all reviewed areas, especially for all change controls that must be promptly and effectively reviewed and closed in a timely basis.
  • Ensures compliant documentation practices and the fundamentals of ALCOA (Attributable, Legible, Contemporaneous and Accurate).
  • Ascertains that all Corrective Actions and their effectiveness checks assist to improve the quality of UL PURE Learning's products and services for our customers.
  • Assists with the integration of enhanced platform features, new or updated course content and change control records are deployed to the platform by reviewing and enhancing current templates and processes to show value-added improvements and verify that the UL PURE Product are meeting all the new feature requirements.
  • Works collaboratively with other IT members, QA, & business functions on validation of new systems and improvement of existing IT Quality processes/practices.
  • Works with Compliance Manager – Compliance and Validation to ensure consistent interpretation and implementation of regulatory controls (e.g., FDA 21 CFR Part 11, new pronouncement, predicate rules, validation and risk-based understanding. Works with Software Quality Assurance Manager – Compliance and Validation to lead/train cross-functional teams in compliance responsibilities and validation activities and will be a resource to help define, continually improve the regulated, computerized system use.
  • Clear understanding of ANSI Sampling Criteria) to all projects, regardless of size, scope or location.
  • Takes the lead on projects improvements and works conjunction with the Software Quality Assurance Manager – Compliance and Validation to implement proper SDLC industry best practices methods (e.g., FDA, OWASP and NIST) as they relate to Quality by Design, Security by Design and Privacy by Design (GDPR) and Computer Systems Validation IT Quality Systems, and Technology in general.
  • Provides computer validation oversight and continual improvement recommendations for IT projects to assure compliance with company policies, standard operating procedures and all applicable regulations and law requirements are accurately addressed.
  • Assists to define and implement global quality systems in support of enhancing the existing risk-based computer validation at the enterprise, business unit and site levels.
  • Participates in internal and external audits, supporting all aspects of compliance and legal activities during audits. Responsible for the developing the announcement memo, planning, developing the audit agenda, scheduling the audits in the tracker with UL PURE Learning's subject matter experts, conducting the all customer calls and audits in a professional and effective manner.
  • Works with Compliance Manager – Compliance and Validation to perform vendor qualifications and audits as required.
  • Performs internal assessments to ascertain compliance to cloud based SaaS offering, risk-based validation, IT policies and procedures.
  • Works with Compliance Manager – Compliance and Validation perform investigation, track and monitors CAPA and ensure all effectiveness checks objective audit evidence is logged and maintained. .
  • Works with offshore testing resources to ensure test scripts and test script execution is complete and meets internal SOPs , regulatory and legal requirements, particularly Good Documentation Practices (GDP) and ALCOA.
  • Verifies all issues (system/course bugs) are tracked in the issue tracking database, issue records are complete, and fixes are verified and satisfactorily resolved.
  • Supports change control procedures, providing accurate, due diligence quality systems review of applicable changes and ensures change control records are satisfactorily resolved and timely notification sent to appropriate team members.
  • Works with Compliance Manager by leading the effort to determine any gaps in the current Compliance and Validation process. Skilled with interviewing the UL PURE Learning team members to draft the applicable SOPs, and Work Instructions. Responsible for maintaining a controlled document for the timely review, consolidation, interviews, development or update of applicable SOPs or WIs.
  • Drafts, reviews and/or approves, validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including validation plans, requirements and specifications, risk and gap assessments, test plans, qualification protocols, phase reports and summary reports. Review all documents for continual improvements.
  • Works with Compliance Manager – Compliance and Validation to ensure all deliverable documents for product releases are created or updated according to release schedule.
  • Complies with regulations of 21 CFR Part 11 and all company processes as outlined in Standard Operating Procedures (SOPs). Knowledgeable and remain current on new US and international regulatory developments ( FDA, GxP), 21 CFR Part 11), laws (Privacy) GAMP5, OWASP, NIST, Risk based validation, , risk management and corporate requirements, system acquisitions, audit findings, CAPA responses and technical progress in computerized systems.
  • Responsible for monthly and quarterly metrics for the Key Performance Indicators and metrics to denote areas for improvement and corrective actions
  • Reviews and approves change controls from the Work Order and product release process. The review must be based on good documentation practices and the principles of ALCOA.
  • Experience with planning, executing and drafting internal audit observations, understanding the risk and ensuring the satisfactory resolution.
  • Responsible for the Training Matrix and ComplianceWire System Administrator duties, overdue assignment reporting, Curriculum Vitae reviews, and another project work as required.
  • Develops risk profiles and assessments for systems, recognizing the appropriate GxP, business and client parameters to develop a business plan to identify cost, timelines of proposed process improvements.
  • Demonstrates understanding of the System Development Lifecycle (SDLC) and the AGILE process and risk-based methodology regarding the mitigation strategy.

Qualifications

  • Minimum of 5 years of software validation requirements and software quality assurance experience
  • 5-10 years' experience in IT or quality, preferably in the Life Science arena.
  • Proficient in GAMP5, FDA methodology and applicable laws (GDPR), and FDA risk-based validation methodology.
  • Excellent soft skills (reading, writing and speaking), ability to conduct and present during customer audits.
  • Excellent time and project management skills.
  • Ability to travel both in the US and international – total time 10%
  • College or University Degree in Biology, IT or related is preferred. Certifications in ISO: 9001 2015 or ISO : 27001 a plus.